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Trial record 3 of 772 for:    "Visceral steatosis"

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis (EASYBEinNASH)

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ClinicalTrials.gov Identifier: NCT03198572
Recruitment Status : Not yet recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The Affiliated Hospital of Hangzhou Normal University
Tianjin Third Central Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xinjiang Medical University
Information provided by (Responsible Party):
Xin Gao, Fudan University

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Behavioral: Lifestyle intervention Drug: Placebo Drug: Berberine Phase 4

Detailed Description:
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Berberine
Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Behavioral: Lifestyle intervention
Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.

Drug: Berberine
Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks

Placebo Comparator: Placebo
Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Behavioral: Lifestyle intervention
Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.

Drug: Placebo
placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks




Primary Outcome Measures :
  1. Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS) [ Time Frame: 48 weeks ]
    A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.


Secondary Outcome Measures :
  1. Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning [ Time Frame: 48 weeks ]
    NAFLD activity score (NAS) is composed of steatosis (scale of 0 to 3), lobular inflammation (scale of 0 to 3), hepatocellular ballooning (scale of 0 to 2). Alteration in each component of NAS is measured.

  2. Improvement in liver histological fibrosis staging [ Time Frame: 48 weeks ]
    Fibrosis staging was measured as following criteria: 0=none, 1=perisinusoidal or periportal fibrosis, 2=perisinusoidal and portal/periportal fibrosis, 3=bridging fibrosis, and 4=cirrhosis.

  3. Change in body weight in kilograms [ Time Frame: 72 weeks ]
  4. Change in waist circumference in meters [ Time Frame: 72 weeks ]
  5. Change in intra-abdominal visceral fat content and abdominal subcutaneous fat content by abdominal MRI in cm^2 [ Time Frame: 72 weeks ]
  6. Change in liver enzymes (ALT, AST, γ-glutamyl transpeptidase[GGT] in IU/L) [ Time Frame: 72 weeks ]
  7. Change in fasting and 2h postload blood glucose in mmol/L [ Time Frame: 72 weeks ]
  8. Changes in fasting insulin in μU/ml [ Time Frame: 72 weeks ]
  9. Changes in insulin resistance index (HOMA-IR) calculated from the value of fasting blood glucose and insulin [ Time Frame: 72 weeks ]
  10. Changes in serum lipid profile (serum triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol in mmol/L) [ Time Frame: 72 weeks ]
  11. Change in liver fat content measured by proton magnetic resonance spectroscopy (1H-MRS) [ Time Frame: 72 weeks ]
  12. Change in serum C-reactive protein (CRP) in mg/L [ Time Frame: 72 weeks ]
  13. Change in serum cytokeratin 18 (CK-18) in U/L [ Time Frame: 72 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 ≤ age ≤ 65 years old.
  • BMI:25-40kg/m2
  • Biopsy-proven NASH within 3 months before enrollment. ( NASH was diagnosed with a NAFLD activity score [NAS] of 5 or more, or a NAS of 4 with at least 1 for steatosis, lobular inflammation, hepatocellular ballooning, respectively
  • Informed consent

Exclusion Criteria:

  • Excessive alcohol intake (> 140 g per week for men and >70 g per week for women within 6 months before enrollment)
  • Liver and renal dysfunction (ALT or aspartate aminotransferase(AST) is 5 times higher than the upper limit of normal, or Cr ≥ 2.0mg/dL).
  • Fatty liver caused by viral hepatitis, auto-immune hepatitis, drug, alcohol, Wilson disease, or total parenteral nutrition.
  • Biliary tract diseases
  • Presence of serious dyslipidemia or other endocrine diseases (hypothyroidism, hyperthyroidism, hypothalamic-pituitary dysfunction, etc).
  • HbA1c >9.5%
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonist, dipeptidyl peptidase -4 (DPP-4) inhibitors, pioglitazone, insulin or glycyrrhizin
  • life expectancy no more than 5 years
  • Pregnancy
  • Use of drugs that may affect liver fat content, such as glucocorticoids, methotrexate, etc.
  • Any situation that may affect the implementation or results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198572


Contacts
Contact: Hong-Mei Yan 8613761666976 yan.hongmei@zs-hospital.sh.cn
Contact: Ming-Feng Xia 8613611826871 xia.mingfeng@zs-hospital.sh.cn

Locations
China, Shanghai
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
Shanghai, Shanghai, China
China
The Affiliated Hospital of Hangzhou Normal University Not yet recruiting
Hangzhou, China
Contact: Jun-Ping Shi         
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China
Contact: Lun-Gen Lu         
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China
Contact: Jian-Gao Fan         
Tianjin Third Central Hospital Not yet recruiting
Tianjin, China
Contact: Fu-Sheng Di         
Xinjiang Medical University Not yet recruiting
Urumqi, China
Contact: Fang-Ping He         
Sponsors and Collaborators
Fudan University
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The Affiliated Hospital of Hangzhou Normal University
Tianjin Third Central Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xinjiang Medical University
Investigators
Principal Investigator: Xin Gao Fudan University

Publications:

Responsible Party: Xin Gao, Director, Fudan University
ClinicalTrials.gov Identifier: NCT03198572     History of Changes
Other Study ID Numbers: 2016ZSLC04
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Xin Gao, Fudan University:
Non-alcoholic steatohepatitis

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases